Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Simvastatin and Anastrozole in Treating Postmenopausal Women With Invasive Breast Cancer, Ductal Carcinoma In Situ, or a High Risk of Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Biomarker/Laboratory analysis, Prevention, Treatment	Closed	Postmenopausal	NCI	JHOC-J05100 J05100, JHOC-SKCCC-J05100, NCT00354640

Objectives

Primary

1. Assess the effects of concurrent anastrozole and simvastatin on anastrozole's steady-state concentration in postmenopausal women with history of invasive breast cancer or ductal carcinoma in situ or at high risk for developing breast cancer.

Secondary

1. Study the effect of concurrent simvastatin and anastrozole on estrogen suppression in these patients.

Entry Criteria

Disease Characteristics:

• Meets any of the following criteria:
  • History of invasive breast cancer
  • History of ductal carcinoma in situ
  • At high risk for breast cancer, defined as being on anastrozole for chemoprevention of breast cancer



• Receiving anastrozole for ≥ 30 days as adjuvant breast cancer treatment or for prevention of breast cancer



• No active breast cancer with known metastatic involvement



• Hormone receptor status not specified

Prior/Concurrent Therapy:

• See Disease Characteristics
• No cholesterol-lowering drug, including a statin, within the past 3 months
• No selective estrogen receptor modulator (SERM) within the past 3 months
• No other hormone therapy within the past 3 months
• No prior estrogen and/or progesterone hormone replacement therapy that lasted for ≥ 5 years
  • Vaginal estrogen preparations allowed
• No other concurrent statin or cholesterol-lowering drug
• No other concurrent SERM
• No other concurrent hormone therapy
• No other concurrent investigational drugs
• No concurrent CYP3A4 inhibitors, including itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone, or cyclosporine
• No concurrent chemotherapy or biological agents
• No concurrent daily grapefruit juice > 8 oz/day
• No other concurrent anticancer agents or therapies

Patient Characteristics:

• Female
• Postmenopausal
• ECOG performance status 0-2
• AST and ALT ≤ 3 times upper limit of normal
• Creatinine clearance ≥ 30 mL/min
• No active liver disease
• No prior hypersensitivity to any HMG-CoA reductase inhibitor or any of its components
• No daily alcohol use of > 3 standard drinks/day
  • A standard drink is defined as 10 g of alcohol, which is equivalent to 285 mL of beer, 530 mL of light beer, 100 mL of wine, or 30 mL of liquor

Expected Enrollment

A total of 20 patients will be accrued for this study.

Outcomes

Percentage change in blood concentrations of anastrozole at 14 days

Percent reduction of serum estradiol levels at 14 days

Outline

This is a pilot study.

Patients continue to receive oral anastrozole once daily (as prior to study entry). They also receive oral simvastatin once daily for 14-18 days in the absence of unacceptable toxicity or diagnosis of new or recurrent breast cancer.

Patients undergo blood sample collection at baseline and after study therapy for analysis of anastrozole and hormone (estradiol and estrogen) concentrations.

Trial Contact Information

Trial Lead Organizations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Vered Stearns, MD, Principal investigator		Ph: 443-287-6489

Registry Information
Official Title		A Trial Assessing the Effect of Simvastatin on the Pharmacokinetics of Anastrozole
Trial Start Date		2006-06-02
Trial Completion Date		2008-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00354640
Date Submitted to PDQ		2006-05-10
Information Last Verified		2009-03-28
NCI Grant/Contract Number		CA06973

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